Olmesartan Medoxomil in Hypertension and Renal Impairment

Phase 3

Completed

• Conditions: Essential Hypertension; Renal Impairment
• Interventions: Drug: Olmesartan medoxomil; Drug: Losartan; Drug: Furosemide oral tablets

• Registration Number: NCT00151827
• Lead Sponsor: Sankyo Pharma Gmbh

Brief Summary

This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-13
• Last Update Posted: 2010-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

Inclusion Criteria

• Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
• Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity

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Exclusion Criteria

• Malignant hypertension or sitting BP greater than 180/109 mmHg;
• Severe heart failure, severe renal disease;
• Recent history of myocardial infarction, stroke or transient ischemic attack;
• History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
• Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
• Treatment with dis-allowed medication;
• Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
• History of drug and/or alcohol abuse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olmesartan medoxomil	Olmesartan medoxomil	Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
Olmesartan medoxomil	Furosemide oral tablets	Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
Losartan	Furosemide oral tablets	Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.
Losartan	Losartan	Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.

Primary Outcome Measures

Name	Time	Method
Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment	Baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;	Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;	Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;	Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks	Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg
Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;	Baseline to 12 and 52 weeks
Changes in serum creatinine after 12 and 52 weeks of treatment	Baseline to 12 and 52 weeks
Rate of patients per dose level after 12 and 52 weeks of treatment	Baseline to 12 and 52 weeks
Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment	Baseline to 4, 12, 24, 36 and 52 weeks